[Federal Register Volume 79, Number 34 (Thursday, February 20, 2014)]
[Proposed Rules]
[Pages 9671-9677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03594]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA-2012-N-0378]
Physical Medicine Devices; Reclassification and Renaming of
Shortwave Diathermy for All Other Uses
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed order; technical correction.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify the shortwave diathermy (SWD) for all other uses, a
preamendments class III device, into class II (special controls), and
to rename the device ``nonthermal shortwave therapy (SWT).'' FDA is
proposing this reclassification on its own initiative based on new
information. FDA is also proposing a technical correction in the
regulation for the carrier frequency for SWD and nonthermal SWT
devices. This proposed action would implement certain regulatory
requirements.
DATES: Submit either electronic or written comments on this proposed
order by May 21, 2014. February 21, 2014FDA intends that SWD devices
for all other uses must comply with the special controls and must
submit a premarket notification (510(k)) within 60 days after the
effective date of the final order. See Section XII for the proposed
effective date of a final order based on this proposed order.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0378, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-N-0378 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993, 301-796-5616,
Melissa.Burns@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by
the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub.
L. 107-250), the Medical Devices Technical Corrections Act of 2004
(Pub. L. 108-214), the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144) established a comprehensive
system for the regulation of medical devices intended for human use.
Section 513 of the FD&C Act (21 U.S.C. 360c) established three
categories (classes) of devices, reflecting the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Section 513(a)(1) of the FD&C Act defines class II devices as those
devices for which the general controls by themselves are insufficient
to provide reasonable assurance of safety and effectiveness, but for
which there is sufficient information to establish
[[Page 9672]]
special controls to provide such assurance.
Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
amended section 513(e) of the FD&C Act, changing the process for
reclassifying a device from rulemaking to an administrative order.
Section 513(e) of the FD&C Act governs reclassification of classified
preamendments devices. This section provides that FDA may, by
administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
a preamendments device. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland Rantos v.
United States Department of Health, Education, and Welfare, 587 F.2d
1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th
Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F.Supp. 382, 389-391 (D.D.C. 1991)) or in light of changes in ``medical
science'' (see Upjohn v. Finch, supra, 422 F.2d at 951). Whether data
before the Agency are past or new data, the ``new information'' to
support reclassification under section 513(e) must be ``valid
scientific evidence,'' as defined in 21 CFR 860.7(c)(2). (See, e.g.,
General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens
Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S.
1062 (1986)).
FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the valid scientific
evidence upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).) Section
513(e)(1) of the FD&C Act sets forth the process for issuing a final
reclassification order. Specifically, prior to the issuance of a final
order reclassifying a device, the following must occur: (1) Publication
of a proposed reclassification order in the Federal Register; (2) a
meeting of a device classification panel described in section 513(b) of
the FD&C Act; and (3) consideration of comments to a public docket.
In accordance with section 513(e)(1) of the FD&C Act, the Agency is
proposing, based on new information that has come to the Agency's
attention, to reclassify SWD for all other uses because general
controls and special controls are sufficient to provide a reasonable
assurance of safety and effectiveness. Therefore, this order proposes
to reclassify SWD for all other uses into class II (special controls)
and to rename the device nonthermal SWT; see Section III for more
information on the name change. In addition, in this proposed order to
reclassify the device to class II with special controls, FDA requires
manufacturers of currently marketed SWD for all other uses to submit
510(k)s.
Section 510(m) of the FD&C Act provides that a class II device may
be exempted from the premarket notification requirements under section
510(k) of the FD&C Act, if the Agency determines that premarket
notification is not necessary to assure the safety and effectiveness of
the device. FDA has determined that premarket notification is necessary
to assure the safety and effectiveness of SWD for all other uses.
II. Regulatory History of the Device
On November 23, 1983, in the Federal Register (48 FR 53047), FDA
published a final rule for classification of SWD for all other uses as
class III requiring premarket approval based on recommendations made by
the Physical Medicine Device Classification Panel of 1979 (the 1979
Panel). The 1979 Panel made preliminary classification recommendations
for physical medicine devices during a series of meetings: August 14
and 15, 1975, March 21 and 22, 1976, March 18, 1977, October 14, 1977,
and March 17, 1978. Included in this group of devices were SWD devices.
The 1979 Panel recommended splitting the classification for SWD
devices: SWD devices that are capable of generating therapeutic heat in
specific areas of the body were recommended to be class II. However,
SWD devices for any use other than delivering therapeutic deep heat
(also referred to as nonthermal SWD) were recommended to be class III.
In 1987, FDA published a clarification by inserting language in the
codified language stating that no effective date had been established
for the requirement for premarket approval for SWD devices for any use
other than delivering therapeutic deep heat (52 FR 17732, May 11,
1987).
In 2009, FDA published an order in the Federal Register under
section 515(i) of the FD&C Act (21 U.S.C. 360i) to call for information
on the remaining class III 510(k) devices (74 FR 16214, April 9, 2009).
In response to that order, FDA received submissions from five SWD
device manufacturers suggesting that nonthermal SWD devices could be
reclassified to class II. The manufacturers stated that safety and
effectiveness of these devices may be assured by general and special
controls. Prior to enactment of FDASIA, FDA published a proposed rule
in the Federal Register (77 FR 39953, July 6, 2012) to require filing
of PMAs for nonthermal SWD devices. FDA received over 240 comments to
the docket in response to the 2012 proposed rule. Comments that
expressed an opinion about the classification of nonthermal SWD devices
were usually in favor of a class II designation. Some comments did not
openly state an opinion, but included arguments against the proposed
rule that could reasonably be interpreted as support for a class II
designation. There were also comments that agreed with a class III
designation.
[[Page 9673]]
In addition to the comments, FDA received five separate submissions to
request a change in the classification of nonthermal SWD from class III
to class II.
Subsequent to the issuance of the proposed rule, FDASIA made
amendments to section 513 of the FD&C Act that required FDA to hold a
panel meeting on the classification of preamendment devices and publish
an administrative order for reclassification of preamendment devices
instead of rulemaking. On May 21, 2013, FDA held a meeting of the
Orthopedic and Rehabilitation Devices Panel (the 2013 Panel), to
discuss the classification of nonthermal SWD devices. There was panel
consensus that although the effectiveness data were very limited,
nonthermal SWD devices did not necessarily fit the regulatory
definition of a class III device (life supporting, life sustaining, or
of substantial importance to health). Coupled with the rationale that
special controls could be established to reasonably demonstrate an
assurance of safety and effectiveness, the 2013 Panel recommended the
device be class II (special controls) for nonthermal SWD devices (Ref.
1). FDA is issuing this proposed order to comply with the procedural
requirements created by FDASIA. As a result, elsewhere in this issue of
the Federal Register, FDA is withdrawing the proposed rule issued on
July 6, 2012, calling for PMAs and PDPs for this device pursuant to
515(b) of the FD&C Act. However, FDA continues to review the merits of
the submissions for requests for reclassification that meet the
requirements under 21 CFR 860.123, submitted in response to the
proposed rule.
III. Device Description
SWD devices intended for therapeutic use produce a radiofrequency
(RF) signal that is generated by electronic circuitry at one of two
frequencies designated by the U.S. Federal Communications Commission
(FCC): 27.12 or 13.56 megahertz (MHz) to induce electrical currents and
voltages in body tissues. The RF signal is delivered to an antenna or
applicator that produces electromagnetic fields external to the
applicator. Electric and magnetic fields are induced in body tissues by
the applicator.
FDA has differentiated two types of SWD devices that have been
cleared through the 510(k) process: thermal and nonthermal. Thermal SWD
devices are designed to deliver therapeutic deep heat below the surface
of the skin. Nonthermal SWD devices do not provide therapeutic deep
heat and do not intend to demonstrate a sustained temperature increase
within the tissue. Nonthermal SWD devices are intended to produce their
effect in tissue only through means other than therapeutic deep
heating.
Because the term diathermy refers to therapeutic elevation of
temperature in the tissues, nonthermal diathermy is a misnomer. FDA is
proposing in this order to modify the name of the identification from
how it is presently written in Sec. 890.5290(b) (21 CFR 890.5290(b))
for additional clarification. FDA is proposing to rename this class of
devices from SWD for all other uses to SWT.
Equipment to deliver SWT can be designed to emit either a pulsatile
(pulsed) or a continuous wave output and sometimes provides both types
of output. Thermal SWD systems cleared by FDA provide continuous wave
or pulsed output and achieve therapeutic deep heating of tissues as
noted above. Nonthermal SWT devices cleared by FDA deliver RF energy
only in a pulsatile fashion and do not provide therapeutic deep heat to
the tissues.
IV. Proposed Reclassification
FDA is proposing that SWD for all other uses be reclassified from
class III to class II. FDA is also proposing to rename these devices
from ``shortwave diathermy for all other uses'' to ``nonthermal
shortwave therapy.'' In this proposed order, the Agency has identified
special controls under section 513(a)(1)(B) of the FD&C Act that, if
finalized, together with general controls (including prescription-use
restrictions) applicable to the devices, would provide reasonable
assurance of their safety and effectiveness. Absent the special
controls identified in this proposed order, general controls applicable
to the device are insufficient to provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, in accordance with sections 513(e) and 515(i) of the
FD&C Act and Sec. 860.130 (21 CFR 860.130), based on new information
with respect to the devices and taking into account the public health
benefit of the use of the device and the nature and known incidence of
the risks of the device, FDA, on its own initiative, is proposing to
reclassify this preamendments class III device into class II. FDA
believes that this new information is sufficient to demonstrate that
the proposed special controls can effectively mitigate the risks to
health identified in Section V, and that these special controls,
together with general controls, will provide a reasonable assurance of
safety and effectiveness for nonthermal SWT devices.
Section 510(m) of the FD&C Act authorizes the Agency to exempt
class II devices from premarket notification (510(k)) submission. FDA
has considered nonthermal SWT devices in accordance with the reserved
criteria set forth in section 513(a) of the FD&C Act and has determined
that the device does require premarket notification (510(k)).
Therefore, the Agency does not intend to exempt this proposed class II
device from premarket notification (510(k)) submission as provided for
under section 510(m) of the FD&C Act. As stated in Section I, FDA will
also require manufacturers of currently marketed SWD for all other uses
devices to submit 510(k)s.
FDA is also proposing a technical correction in the regulation for
the carrier frequency for these devices from ``13 MHz to 27.12 MHz'' to
``13.56 MHz or 27.12 MHz.'' The FCC has allocated the shortwave
frequencies of 13.56 MHz and 27.12 MHz for medical equipment (Ref. 2).
This applies to both SWD devices for use in applying therapeutic deep
heat for selected medical conditions (Sec. 890.5290(a)) and nonthermal
SWT devices (Sec. 890.5290(b)).
V. Risks to Health
After considering available information, including the
recommendations of the panel meeting on nonthermal SWT devices held on
May 21, 2013, FDA has reevaluated the risks to health associated with
the use of nonthermal SWT and made revisions from those previously
identified in a proposed rule issued in the Federal Register on July 6,
2012 (77 FR 39953). FDA has determined that the following risks to
health are associated with the use of nonthermal SWT:
Cellular or tissue injury: Nonthermal biological effects
of nonionizing radiation may cause cellular or tissue injury.
Electromagnetic interference: The electromagnetic fields
generated by the device may interfere with the circuitry of other
patient systems, causing adverse events in the patient, as well as
adversely affecting the performance of the other patient systems, such
as cardiac pacemaker and implantable defibrillator.
Tissue necrosis (tissue death) and burns: Excessive energy
deposition into the tissue may cause excessive heating that results in
tissue damage.
Electrical shock: Electrical shock hazards may pose a
potential hazard to both operators and users. Excessive leakage current
from the device could
[[Page 9674]]
result in injury, or a malfunction of the device could result in
electrical shock.
Thermal injury from implanted leads and implanted systems
with leads: Interaction of the RF energy with an implanted lead may
cause excessive heating in the tissue surrounding the lead electrodes.
Adverse tissue reaction: Device materials that are not
biocompatible may either directly or through the release of their
material constituents: (i) produce adverse local or systemic effects,
(ii) be carcinogenic, or (iii) produce adverse reproductive and
developmental effects. Although medical devices may have myriad
biocompatibility issues, the biocompatibility concerns from nonthermal
SWT devices are likely limited to skin reactions from contact with the
materials from which the applicator is made.
Adverse pregnancy outcome: Exposure to the device during
pregnancy can lead to congenital anomalies.
Risk to children: Exposure to the device can affect the
growth plates in children if applied over the growth plates.
Ineffective treatment: Ineffective treatments can result
in increased morbidity, delayed discharge after ambulatory surgery, and
hospital readmission.
The following additional risks to health were identified by the
submitters and acknowledged by the 2013 Panel: Pain, bleeding, feeling
chilly and cold in response to treatment, pins and needles sensation,
gout attack in patients with pre-existing gout, mild numbness in the
area of treatment, abdominal pain, chest wall sensation, malaise, and
headache. Many of these are infrequent and related to pain (which is
already present in this patient population), the underlying condition
being treated, or to the surgical procedures that precede the use of
the device. Therefore, FDA does not consider these additional risks to
health as being associated with the use of nonthermal SWT. The 2013
Panel also acknowledged the risk of cancer progression and metastasis,
although there was some disagreement among panel members on whether it
should be included. This risk was primarily based on literature from in
vitro test data, which associates device use with the upregulation of
certain cytokines and proteases that play a role in metastasis. FDA is
not aware of any animal data, clinical data, or adverse event reports
that attribute cancer progression or metastasis to nonthermal SWT.
Therefore, FDA does not consider this a risk as being associated with
the use of nonthermal SWT.
VI. Summary of Reasons for Reclassification
Based on the comments from the 2013 Panel meeting, the comments
received in response to FDA's prior proposed rule (77 FR 39953, July 6,
2012), and FDA's assessment of new, valid scientific data related to
the health benefits and risks associated with nonthermal SWT, FDA is
proposing that these devices should be reclassified from class III to
class II because special controls, in addition to general controls, can
be established to provide reasonable assurance of safety and
effectiveness of the device, and because general controls themselves
are insufficient to provide a reasonable assurance of its safety and
effectiveness. In addition, there is now sufficient information to
establish special controls to provide such assurance.
FDA has been reviewing these devices for many years, and their
risks are well known. A review of the applicable clinical literature
indicates that few relevant adverse events have been reported for these
devices or related devices suggesting that the device has a long-term
safety profile. If properly manufactured and used as intended, FDA
believes that the special controls identified in this proposed order,
if finalized, together with general controls (including prescription-
use restrictions and 510(k) notification requirements), are adequate to
provide a reasonable assurance of safety and effectiveness for this
device.
VII. Summary of Data Upon Which the Reclassification Is Based
FDA believes that the identified special controls, in addition to
general controls, are sufficient to provide reasonable assurance of
safety and effectiveness of these devices. Therefore, in accordance
with sections 513(e) and 515(i) of the FD&C Act and Sec. 860.130,
based on new information with respect to the device and taking into
account the public health benefit of the use of the device and the
nature and known incidence of the risk of the device, FDA, on its own
initiative, is proposing to reclassify this preamendments class III
device into class II. The Agency has identified special controls that
would provide reasonable assurance of their safety and effectiveness.
FDA's review of the clinical literature has been previously summarized
in the Executive Summary to the 2013 Panel meeting to discuss
nonthermal SWT classification (Ref. 3).
In addition, the 2013 Panel reviewed and discussed recent
information presented by FDA, manufacturers of SWT devices, and members
of the public. This information included recent literature regarding
the possible risks to health and a review of FDA's Manufacturer and
User Facility Device Experience database.
The 2013 Panel agreed that nonthermal SWT devices are not ``life-
supporting or life-sustaining, or of substantial importance in
preventing impairment of human health.'' The 2013 Panel agreed on the
potential risks to health identified by FDA and the additional risks to
health identified in the comments received in response to the July 6,
2012, proposed rule (77 FR 39953). However, the 2013 Panel expressed
uncertainty regarding ``abnormal cell growth'' as a risk to health, but
suggested that cell membrane injury is also a potential risk to health.
The 2013 Panel recommended that the following additional risks to
health be included, as they were reported by those who submitted
requests to change the classification: Adverse pregnancy outcome,
cancer and tumor promotion, skin reactions, pain, bleeding, ineffective
treatment, risk to children, feeling chilly and cold in response to
treatment, sensation of localized warmth, pins and needles sensation,
gout attack in patients with pre-existing gout, mild numbness in the
area of treatment, abdominal pain, chest wall sensation, and headache.
FDA acknowledges cellular or tissue injury, electromagnetic
interference, tissue necrosis (tissue death) and burns, electrical
shock, thermal injury from implanted leads and implanted systems with
leads, adverse tissue reaction, adverse pregnancy outcome, risk to
children, and ineffective treatment as risks to health for these
devices. As explained in Section V, FDA does not believe valid
scientific evidence supports the other additional risks identified by
the 2013 Panel as being associated with the use of nonthermal SWT.
Regarding the benefits of nonthermal SWT devices, the 2013 Panel
indicated that a certain subset of patients may benefit, but there were
concerns about the veracity and the limitations of clinical trials
reported in the literature. They further commented that there was
limited clinical evidence presented to demonstrate effectiveness. The
most compelling effectiveness evidence was presented for post-breast
surgery. The 2013 Panel noted that the effect on edema was less
convincing.
Regarding classification, there was general panel consensus that
[[Page 9675]]
nonthermal SWT devices for adjunctive used in palliative treatment of
postoperative pain and edema should be class II devices with special
controls. There was also general consensus by the 2013 Panel that
special controls that included labeling, biocompatibility testing,
electrical safety testing, electromagnetic compatibility, nonclinical
performance testing, and clinical performance data were appropriate.
The 2013 Panel recommended that clinical data are necessary as a
special control and also recommended studies should include the
following basic study design elements:
Randomization;
Sham control group;
Well-defined patient population, e.g. patients having a
specific surgical procedure;
Well-defined SWT treatment parameters and device settings;
Clinically relevant validated measures of effectiveness;
Adequate power and sample size;
Appropriate predefined statistical methods;
Predefined hypothesis and success criteria; and
Systematic collection of adverse events.
No 2013 Panel member recommended leaving these devices in class
III. Regarding the issue of general controls, the 2013 Panel agreed
that general controls alone are not sufficient to provide reasonable
assurance of the safety and effectiveness of nonthermal SWT devices.
VIII. Proposed Special Controls
FDA believes that the following special controls, in addition to
general controls, are sufficient to mitigate the risks to health
described in Section V:
1. Components of the device that come into human contact must be
demonstrated to be biocompatible. These devices can contact users' skin
directly; therefore, a demonstration of biocompatibility would mitigate
the risks of skin reactions.
2. Appropriate analysis/testing must demonstrate that the device is
electrically safe and electromagnetically compatible in its intended
use environment. The requirement to demonstrate electromagnetic
compatibility would, in concert with other special controls, help
ensure the mitigation of discomfort, pain, and tenderness resulting
from burns to the skin due to excessive energy deposition by preventing
electromagnetic interference with device hardware and software. In
addition, this requirement would ensure the device does not interfere
with other electrical equipment and would also ensure that both
operators and users are properly protected from electrical hazards such
as electrical shock.
3. Non-clinical testing must demonstrate that the device performs
as intended under anticipated conditions of use. Non-clinical
performance testing must characterize the output waveform of the device
and demonstrate that the device meets appropriate output performance
specifications. This requirement would mitigate the risks of cellular
or tissue injury, electromagnetic interference, tissue necrosis and
burn, and thermal injury from implanted leads and implanted systems.
The output characteristics and the methods used to determine these
characteristics, including the following, must be determined:
Peak output power;
Pulse width;
Pulse frequency;
Duty cycle;
Characteristics of other types of modulation that may be
used;
Average measured output powered into the RF antenna/
applicator;
Specific absorption rates in saline gel test load;
Characterization of the electrical and magnetic fields in
saline gel test load for each RF antenna and prescribed RF antenna
orientation/position; and
Characterization of the deposited energy density in saline
gel test load.
4. Documented clinical performance testing must demonstrate safe
and effective use of the device. This requirement would mitigate
ineffective treatment.
5. The labeling must include a detailed summary of the clinical
testing pertinent to the use of the device and a summary of the adverse
events and complications. This requirement would help mitigate the risk
of adverse pregnancy outcome, risk to children, thermal injury from
implanted leads and implanted systems with leads, electromagnetic
interference, electric shock, tissue necrosis and burn, adverse tissue
reaction, and ineffective treatment.
Table 1 shows how FDA believes that the risks to health identified
in Section V can be mitigated by the proposed special controls.
Table 1--Health Risks and Mitigation Measures for Nonthermal SWT
------------------------------------------------------------------------
Identified Risk Mitigation Measure
------------------------------------------------------------------------
Cellular or tissue injury......... Non-clinical characterization and
performance testing.
Electromagnetic interference...... Electromagnetic compatibility
testing.
Non-clinical characterization and
performance testing.
Labeling.
Tissue necrosis (tissue death) and Non-clinical characterization and
burns. performance testing.
Electrical Safety Testing.
Labeling.
Electrical shock.................. Electrical safety testing.
Labeling.
Thermal injury from implanted Non-clinical characterization and
leads and implanted systems with performance testing.
leads. Labeling.
Adverse tissue reaction........... Biocompatibility.
Labeling.
Adverse pregnancy outcome......... Labeling.
Risk to children.................. Labeling.
Ineffective treatment............. Clinical performance data.
Labeling.
------------------------------------------------------------------------
In addition, under 21 CFR 801.109, the sale, distribution, and use
of these devices are restricted to prescription use. Prescription use
restrictions are a type of general controls in section 513(a)(1)(A)(i)
of the FD&C Act. Also,
[[Page 9676]]
under 21 CFR 807.81, the device would continue to be subject to 510(k)
notification requirements.
IX. Environmental Impact
The Agency has determined under 21 CFR 25.34(b)) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
X. Paperwork Reduction Act of 1995
This proposed order refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 807, subpart E, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 814, subpart B, have been approved under OMB control number
0910-0231; and the collections of information under 21 CFR part 801
have been approved under OMB control number 0910-0485.
No burden shift is associated with the reclassification of the
device. This is currently a class III device for which manufacturers
must submit a premarket notification (510(k)). This order proposes to
reclassify the device into class II, therefore, respondents would
continue to submit a premarket notification.
XI. Codification of Orders
Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices. Although
section 513(e) of the FD&C Act as amended requires FDA to issue final
orders rather than regulations, FDASIA also provides for FDA to revoke
previously issued regulations by order. FDA will continue to codify
classifications and reclassifications in the Code of Federal
Regulations (CFR). Changes resulting from final orders will appear in
the CFR as changes to codified classification determinations or as
newly codified orders. Therefore, under section 513(e)(1)(A)(i), as
amended by FDASIA, in this proposed order we are proposing to revoke
the requirements in Sec. 890.5290(b)(1) related to the classification
of shortwave diathermy devices for all other uses as class III devices
and to codify the reclassification of nonthermal SWT devices into class
II (special controls).
XII. Proposed Effective Date
FDA is proposing that any final order based on this proposed order
become effective on the date of its publication in the Federal Register
or at a later date if stated in the final order. FDA proposes that
nonthermal SWT devices must comply with the special controls and must
submit a 510(k) within 60 days after the effective date of the final
order. FDA requests comment on whether 60 days is an appropriate time
to allow manufacturers to prepare and submit 510(k)'s for these
devices.
XIII. Comments
Comments submitted to the previous docket (Docket No. FDA-2012-N-
0378) have been officially noted and do not need to be resubmitted. FDA
has considered previous docket comments before issuing this proposed
order. Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
XIV. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
1. FDA's Orthopedic and Rehabilitation Devices Panel transcript and
other meeting materials are available on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm.
2. 47 CFR Part 18--Industrial, Scientific, And Medical Equipment,
Subpart C, Sec. 18.301 is available at http://www.gpo.gov/fdsys/pkg/CFR-2009-title47-vol1/xml/CFR-2009-title47-vol1-part18.xml.
3. Executive Summary of the Orthopedic and Rehabilitation Devices
Panel meeting is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm.
List of Subjects in 21 CFR Part 890
Medical devices, Physical medicine devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq., as amended) and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 890 be
amended as follows:
PART 890--PHYSICAL MEDICINE DEVICES
0
1. The authority citation for 21 CFR part 890 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 890.5290 is amended by revising paragraphs (a)(1) and (b),
and removing paragraph (c) to read as follows:
Sec. 890.5290 Shortwave diathermy.
(a) Shortwave diathermy for use in applying therapeutic deep heat
for selected medical conditions--(1) Identification. A shortwave
diathermy for use in applying therapeutic deep heat for selected
medical conditions is a device that applies to specific areas of the
body electromagnetic energy in the radiofrequency (RF) bands of 13.56
megahertz or 27.12 megahertz and that is intended to generate deep heat
within body tissues for the treatment of selected medical conditions
such as relief of pain, muscle spasms, and joint contractures, but not
for the treatment of malignancies.
(2) * * *
(b) Nonthermal shortwave therapy--(1) Identification. A nonthermal
shortwave therapy is a prescription device that applies to the body
pulsed electromagentic energy in the RF bands of 13.56 megahertz or
27.12 megahertz and that is intended for the treatment of medical
conditions except for the treatment of malignancies by means other than
the generation of deep heat within body tissues as described in
paragraph (a) of this section.
(2) Class II (special controls). The device is classified as Class
II. The special controls for this device are:
(i) Components of the device that come into human contact must be
demonstrated to be biocompatible;
(ii) Appropriate analysis/testing must demonstrate that the device
is electrically safe and electromagnetically compatible in its intended
use environment;
(iii) Non-clinical performance testing must demonstrate that the
device
[[Page 9677]]
performs as intended under anticipated conditions of use. Non-clinical
performance testing must characterize the output waveform of the device
and demonstrate that the device meets appropriate output performance
specifications. The output characteristics and the methods used to
determine these characteristics, including the following, must be
determined:
(A) Peak output power;
(B) pulse width;
(C) pulse frequency;
(D) duty cycle;
(E) characteristics of other types of modulation that may be used;
(F) average measured output powered into the RF antenna/applicator;
(G) specific absorption rates in saline gel test load;
(H) characterization of the electrical and magnetic fields in
saline gel test load for each RF antenna and prescribed RF antenna
orientation/position; and
(I) characterization of the deposited energy density in saline gel
test load.
(iv) Documented clinical performance testing must demonstrate safe
and effective use of the device.
(v) Labeling must include a detailed summary of the clinical
testing pertinent to the use of the device and a summary of the adverse
events and complications.
Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03594 Filed 2-19-14; 8:45 am]
BILLING CODE 4160-01-P